Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction

NCT07745959 | Not Yet Recruiting

• 1 other identifier: ArdahanU-Simsekli-DS-07
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction. Methods: This randomized controlled trial will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients scheduled to undergo upper gastrointestinal endoscopy will be enrolled and randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group. Participants in the intervention group will receive a virtual reality application before the endoscopy procedure, whereas participants in the control group will receive standard care. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, and patient satisfaction will be assessed immediately after the procedure. Expected Results: It is anticipated that the virtual reality intervention will reduce preprocedural anxiety, improve psychological readiness, and increase postprocedural satisfaction compared with standard care.

Conditions

Upper Gastrointestinal Disorders

Keywords

Virtual Reality; Upper Gastrointestinal Endoscopy; Preprocedural Anxiety; Psychological Readiness; Patient Satisfaction; State Anxiety; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Preprocedural Anxiety

  Preprocedural anxiety will be assessed using the State Anxiety Inventory (STAI-I). The STAI-I consists of 20 items scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.

  Immediately before upper gastrointestinal endoscopy

Secondary Outcomes (2)

• Psychological Readiness

  Immediately before upper gastrointestinal endoscopy

• Postprocedural Satisfaction

  Immediately after upper gastrointestinal endoscopy

Study Arms (2)

Experimental

EXPERIMENTAL

Participants will receive a virtual reality intervention before upper gastrointestinal endoscopy in addition to standard preprocedural care. The virtual reality application will be administered before the endoscopy procedure using a virtual reality headset.

Device: Virtual Reality

Standard Care Group

ACTIVE COMPARATOR

Participants will receive a virtual reality intervention using a virtual reality headset before upper gastrointestinal endoscopy. The intervention is designed to reduce preprocedural anxiety, improve psychological readiness, and enhance patient satisfaction.

Other: Standard Preprocedural Care

Interventions

Virtual Reality DEVICE

Participants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention.

Experimental

Standard Preprocedural Care OTHER

Participants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality.

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Scheduled to undergo upper gastrointestinal endoscopy
• Able to understand and communicate in Turkish
• Willing to participate in the study
• Providing written informed consent

You may not qualify if:

• Presence of a diagnosed psychiatric or neurological disorder that may interfere with participation
• Presence of a visual, hearing, head, face, or eye condition that prevents the use of a virtual reality headset
• History of severe vertigo, motion sickness, or balance disorder
• Development of severe dizziness, nausea, eye strain, or discomfort during the virtual reality intervention
• Refusal to participate or withdrawal from the study

Sponsors & Collaborators

• Ardahan University: lead
• Gümüşhane Universıty: collaborator

Study Sites (1)

Atatürk University Research Hospital

Erzurum, 25400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Patient Satisfaction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Digestive System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• DERYA ŞİMŞEKLİ, Dr.

  Ardahan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DERYA ŞİMŞEKLİ, PhD

CONTACT

+905545965789; deryasimsekli@ardahan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participant and investigator blinding was not feasible. To minimize assessment bias, group allocation will be coded as Group 1 and Group 2 before statistical analysis, and the statistician (outcome assessor) will remain blinded to group allocation until all analyses have been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the standard care control group using block randomization.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)